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FDA Approves Dangerous ‘Ella’ Abortion Drug as Contraception

LifeSiteNews.com
LifeSiteNews.com

By Peter J. Smith

WASHINGTON, D.C., August 13, 2010 (LifeSiteNews.com) –  The U.S. Food & Drug Administration (FDA) approved Friday afternoon HRA Pharma’s “ella,” a new drug billed as an advanced form of "emergency contraception," for sale and distribution in the United States. However, pro-life advocates have raised the alarm on the drug’s safety and testing, and say ella is little more than a chemical abortion drug similar to RU-486, remarketed to the public as contraception. 

The FDA’s unanimous decision allows the drug to be marketed in the United States as an “occasional” emergency contraception, taken by a woman up to five days after sexual intercourse. The FDA warned, however, that it was unsafe for women to use ella more than occasionally, as they had no data on its safety over the long term. They also warned that women should be ruled out as pregnant before being prescribed ella, and women experiencing lower abdominal pain or who become pregnant after taking ella should be checked by their health care providers for ectopic pregnancy. (see release)

Pro-life leaders, however, were upset with the federal regulatory agency’s decision to approve the drug, pointing out that ella chemically works the same as RU-486. Therefore it not only can cause an abortion, but may also pose a risk to a woman’s health and life, and even have an adverse effect on later pregnancies. 

“The FDA underscored the point that this decision was driven by politics by releasing it late on a Friday when people are not paying attention,” said Wendy Wright, President of Concerned Women for America. “The meager trials done on ella indicate it may cause miscarriages and birth defects. Yet the FDA allowed the HRA Pharma to avoid fully testing the drug so women will be kept in the dark on what kind of serious complications it may cause to her and her baby.”

The chemical name for ella is ulipristal acetate, which functions as a progestin-blocker, or "selective progesterone receptor modulator (SPRM)."

Other forms of emergency contraception work by releasing massive amounts of progesterone into a woman's body, thereby suppressing ovulation, inhibiting sperm migration and reducing sperm capacity for fertilization. This can also have an abortifacient effect if the influx of progesterone changes the lining of the womb, preventing an already conceived embryo from implanting.

But ulipristal acetate works far differently, with far more effective abortifacient results. As a SPRM, it turns off the progesterone receptors in the body crucial not only for the beginning of pregnancy, but its continuance.

Mifeprostone, the drug taken in the two step RU-486 regimen, is also a SPRM, which also has been found to have had thousands of "adverse event reports" related to its use. Since the FDA approved it for sale in 2000, Mifepristone has been tied to 13 confirmed deaths, 9 of which were reported in the U.S. As of May 2006, when the FDA began reporting cases of women suffering from adverse effects of RU-486, 1,070 events were recorded, including six deaths, 9 life-threatening incidents, 232 hospitalizations, 116 blood transfusions, and 88 cases of infection. 

Wright added that the best regulatory defense for women may be trial lawyers: the FDA, she said, appears to hold reproductive drugs to a lower standard than other drugs, and “treats serious complications and even death as preferable to pregnancy.”

“Make no mistake about it, ella is a dangerous abortion drug,” said Kristan Hawkins, Executive Director of Students for Life of America, in a statement calling upon the FDA to review and reverse its decision. “The FDA’s approval of ella for sale within the U.S. shows that the FDA has not done its job protecting women, particularly young women whom SFLA serves on a daily basis.” 
Students for Life of America and the “ella Causes Abortions Coalition” released a video Friday afternoon highlighting their concerns with ella’s possible effects and other questions unanswered by HRA Pharma. 

Unfortunately, little data currently exists to answer these questions. Ulipristal acetate was studied by the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP), but they admitted they lacked any concrete information as to the effects of the drug on women who do get pregnant. In 29 cases of women who became pregnant while testing ulipristal, 16 chose to have an induced abortion, six miscarried, another six said they were going to carry their babies to term, but they received no information regarding the status of their pregnancies.

But the labeling of ella as an emergency contraceptive, rather than an early abortion-inducing drug, may actually have another financial motive for HRA Pharma: the U.S. federal government may end up its biggest single customer. 

“By misclassifying ella as emergency contraception, this administration has paved the way to covertly allow federal funding for abortion through Medicaid, Title X, and international family planning programs,” said U.S. Rep. Chris Smith (R-N.J.), co-chairman of the bipartisan Congressional Pro-Life Caucus. Given President Barack Obama’s ideological commitment to abortion, said Smith, it was no surprise.

The congressman urged another Executive Order from President Obama preventing the federal government from funding ella or forcing insurance companies to cover it as an essential benefit. 

“The FDA is supposed to protect people from dangerous drugs and deceptive marking. Instead, today they have proven they are willing to be complicit in this abortion cover-up,” said Smith.

“At a minimum the drug should be classified as an abortion drug.  Women deserve to know that these pills they believe prevent pregnancy could actually kill their unborn child by withholding vital nutrients and effectively starving the child to death.”
 
See related coverage by LifeSiteNews.com:

FDA Readies Public Hearing for Next Generation Abortion Drug
http://www.lifesitenews.com/ldn/2010/jun/10060211.html 

Pro-life blogger concerned after RU-486 abortion Tweeter goes silent 
http://www.lifesitenews.com/ldn/2010/mar/10031208.html

Oregon Planned Parenthood Offers RU-486 Abortion in 'Privacy of Their Home' 
http://www.lifesitenews.com/ldn/2010/feb/10022513.html

Planned Parenthood Implicated in RU-486 Deaths of Four Women 
http://www.lifesitenews.com/ldn/2008/jun/08061907.html

Leading Researcher Proves RU-486 Causes Septic Shock Deaths 
http://www.lifesitenews.com/ldn/2005/jul/05072802.html

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Lisa Bourne

‘You can’t have’ marriage equality ‘without polygamy’

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By Lisa Bourne

July 3, 2015 (LifeSiteNews) – Motivated by the U.S. Supreme Court ruling legalizing homosexual “marriage,” a Montana polygamist has filed for a second marriage license, so he can be legally wed to two women at once.

"It's about marriage equality," said Nathan Collier, using homosexual advocates’ term to support marriage redefinition. "You can't have this without polygamy."

Collier, who has has appeared on the TLC reality show Sister Wives with his legal wife Victoria, and his second wife Christine, said he was inspired by the dissent in the Supreme Court decision.

The minority Supreme Court justices said in Friday’s ruling it would open the door to both polygamy and religious persecution.

“It is striking how much of the majority’s reasoning would apply with equal force to the claim of a fundamental right to plural marriage,” wrote Chief Justice John Roberts.

Collier and his wives applied for a second marriage license earlier this week at the Yellowstone County Courthouse in Billings, a report from the Salt Lake Tribune said.

Collier, who was excommunicated from the Mormon Church for polygamy, married Victoria in 2000 and had a religious wedding ceremony with Christine in 2007. The three have seven children between them and from previous relationships.

"My second wife Christine, who I'm not legally married to, she's put up with my crap for a lot of years. She deserves legitimacy," Collier said.

Yellowstone County officials initially denied the application before saying they would consult with the County Attorney and get him a final answer.

Click "like" if you want to defend true marriage.

Bigamy, the holding of multiple marriage licenses, is illegal all 50 states, but Collier plans to sue if his application is denied. Officials expect to have an answer for him next week.

While homosexual “marriage” supporters have long insisted legalization of same-sex unions would not lead to polygamy, pro-life and family advocates have warned all along it would be inevitable with the redefinition of marriage.

“The next court cases coming will push for polygamy, as Chief Justice John Roberts acknowledged in his dissent,” said Penny Nance, president of Concerned Women for America, after the Supreme Court ruling. “The chief justice said “the argument for polygamy is actually stronger than that for ‘gay marriage.’ It’s only a matter of time.”

In a piece from the Washington Times, LifeSiteNews Editor-in-Chief and the co-founder of Voice of the Family John-Henry Westen stated the move toward legal polygamy is “just the next step in unraveling how Americans view marriage.”

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Chris Christie: Clerks must perform same-sex ‘marriages’ regardless of their religious beliefs

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By Ben Johnson

TRENTON, NJ, July 3, 2015 (LifeSiteNews) – Chris Christie is not known for nuance. This time, he has turned his fiery personality loose on county clerks and other officials who have religious objections to performing same-sex “marriages.”

In a tone usually reserved for busting teachers' unions, Christie told clerks who hold traditional values, “You took the job, and you took the oath.” He would offer no exemption for an individual whose conscience would not allow him to participate in a union the vast majority of the world's religions deem sinful.

“When you go back and re-read the oath it doesn’t give you an out. You have to do it,” he said.

He told a reporter that there “might” be “individual circumstances” that “merit some examination, but none that come immediately to mind for me.”

“I think for folks who are in the government world, they kind of have to do their job, whether you agree with the law or you don’t,” the pugnacious governor said.

Since the Supreme Court voted 5-4 to legalize homosexual “marriage” last Friday, elected officials have grappled with how to safeguard the rights of those who have deeply held religious beliefs that would not allow them to participate in such a ceremony.

Christie's response differs markedly from other GOP hopefuls' responses to the Supreme Court ruling. Mike Huckabee, for instance, has specifically said that clerks should have conscience rights. Louisiana Gov. Bobby Jindal signed an executive order granting such rights and ordered clerks to wait until a pending court case was fully adjudicated before any clerk issues a marriage license to a homosexual couple.

Christie gave up a legal appeal after a superior court judge struck down his state's voter-approved constitutional marriage protection amendment. New Jersey is the only state where such a low court overturned the will of the voters.

The decision to ignore conscience rights adds to the growing number of Christie's positions that give conservatives pause.

The natural locus of support for a Christie 2016 presidential run is the Republican's socially liberal donor class, for personal as well as political reasons. His wife works on Wall Street, and some of the GOP's high-dollar donors – including Paul Singer – have courted Christie for years.

However, this year Jeb Bush, Marco Rubio, and to a lesser degree Scott Walker have eclipsed Christie as the preferred candidates of the boardroom donors – who sometimes prefer Democrats to Republicans.

Christie also used language during a speech before the Republican Jewish Coalition last year, which concerned some major GOP donors.

Christie is reportedly spending this weekend with Mitt Romney and his family at Romney's New Hampshire home. Romney declined to enter the 2016 race himself and may be able to open his donor list to Christie's struggling campaign.

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After having a girl with Down syndrome, this couple adopted two more

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By Ben Johnson

LINO LAKE, MN, July 3, 2015 (LifeSiteNews) – For most people, having five biological children would have been enough. In fact, for many Americans, large families are treated as a scandal or a burden.

But one family made the decision, not just to have a large family, but to give a home to some of the most vulnerable children in the world: Girls born overseas with Down syndrome.

Lee and Karen Shervheim love all seven of their children, biological or otherwise. Undeterred by having twin boys – Daniel and Andrew, 18 – they had Sam four years later.

They now have three daughters who are all 11 years old. All three have Down syndrome.

And two of them are adopted.

About the time their eight-year-old son, David, was born, Lee and Karen decided to adopt a child with Down syndrome to be a companion to their daughter, Annie.

They made the further unexpected choice to adopt a child from Eastern Europe with the help of Reece's Rainbow, which helps parents adopt children with Down syndrome.

“Between my wife and I, we couldn’t get it out of our heads,” Lee told the Quad City Press. “So many children need families and we knew we could potentially do something about it.”

After originally deciding to adopt Katie, they spent six weeks in Kiev, visiting an orphanage in nearby Kharkov. While there, they decided they may have room in their heart, and their home, for another child.

When they saw a picture of Emie striking the same pose as their biological daughter in one of their photographs, they knew they would come home with two children.

Both girls were the same age as their Annie. She would not lack for companionship, as they worried.

Lee said after the Ukrainian government – finally – completed the paperwork, they returned to the United States, when the real challenges began.

“The unvarnished truth,” Lee told the Press, is that adopting the Russian-speaking special needs children “was really disruptive to our family. They came with so many issues that we had not anticipated.”

After teaching them sign language and appropriate behavior, they moved to Lino Lake, Minnesota and found a new support group in Eagle Brook Church. There they found personal assistance and spiritual solace.

Every year in the past seven years has been better and better, they say.

“I think my girls can do almost anything they want to do,” he said, “and that’s what I want to help them become.”

The family's devotion is fueled by their faith, and it informs the sense of humor Lee showed in a tweet during the 2014 midterm elections:

It takes a special person to believe in the potential of the “mentally retarded,” as they were once labeled. Today, 90 percent of all babies diagnosed with Down syndrome in the womb will be aborted. The percentage is higher in some countries. Some have even spoken of "a world without people with Down syndrome."

Their God, and their experience, tell them that every child has infinite worth and potential, Lee told local media, and he would encourage anyone to follow his footsteps and adopt a Down syndrome child – or two.

“The message is that it really doesn’t matter where you started or where you came from,” Lee said. “There are endless opportunities for everyone, whether they have disabilities or not. They deserve a shot.”

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